1. Field of the Invention
The invention relates to a device for appliances for ostomy, fistula, wound or drain site treatment.
In connection with surgery for a number of diseases in the gastro-intestinal tract a consequence is, in many cases, that the colon, the ileum or the urethra has been exposed surgically and the patient is left with an abdominal stoma and the effluents or waste products of the body, which are conveyed through these organs, are discharged through the artificial orifice or opening and are collected in a collection bag, which is usually adhered to the skin by means of an adhesive wafer or plate having an inlet opening for accommodating the stoma. Also in connection with a fistula, the patient will have to rely on an appliance to collect the bodily material emerging from such opening.
Wafers of appliances for ostomy, fistula, wound or drain site treatment are manufactured in a variety of different standard shapes, sizes and configurations to meet the many different needs of the users. Although these standard products meet the needs of the average user, they do not ideally meet the needs of any particular individual. In most cases, the user must adapt the product prior to use to suit his or her anatomy or lifestyle. Typical modifications, which can be performed include cutting of the aperture in the wafer for receiving the wound or opening in tissue the wafer. Where the aperture for a stoma may be substantially the same for the same patient and thus a number of wafers may be provided with an aperture custom made for this particular patent, a wound or fistulae may change contours and size over time and thus a new customized aperture has to be made for each appliance.
2. Description of the Related Art
Methods for recording the size and shape of wounds are well known:
In EP patent application No. EP 730 845 is disclosed a device for measuring wound surface. The device is in the form of a transparent sheet being folded to provide two superimposed sheets. A perforated line may separate the sheets from each other's. The double layer is placed over the wound; the contours of the wound are marked with a marking device on the top layer. Then the second layer, facing the wound and being smeared by wound exudates, are removed by tearing along the perforated line. The sheet with the markings is saved in the patients file.
U.S. Pat. No. 5,265,605 discloses a wound assessment tool in the form of a first transparent sheet, adhered to a second transparent sheet. The combined sheets are placed over the wound, the contours of the wound are marked up on the upper sheet, and then the lower sheet is removed and discarded, and the upper sheet, with the drawing of the wound, is saved for the record in the patients file.
EP patent application No. EP 640 332 discloses a wound dressing in a package, wherein the package may be used as a wound assessment tool. One side of the package serves as a protection layer against exudates from the wound while the other layer is for recording the size of the wound. The protection layer is discarded after use and the record layer is saved for the file.
None of the above-mentioned references provides a method for transferring the image of the wound to an appliance, on the contrary, if they were used for this purpose a mirror image would occur on the appliance, which would be unusable for this purpose.
Methods for preparing customized apertures in ostomy appliances are also known. In EP Patent No. 1 124 516 is disclosed a method for making a customized ostomy appliance comprising the steps of: measuring the outer contour of the stoma of the patient, recording the information relating to the measurements and transforming the recorded information into electronic form, and utilizing the information for printing a cutting guide pattern on a material for adhering to the adhesive wafer of the appliance. The method is only applicable when a large number of identical apertures are desired.
Thus there is still a need for a device for recording and transferring an image of a wound or opening in tissue to an appliance for ostomy, fistula, wound or drain site treatment.